Class 2 Device Recall EasyTouch (ET) Insulin Syringe

• Date Initiated by Firm: April 06, 2018
• Create Date: May 09, 2018
• Recall Status: Open, Classified
• Recall Number: Z-1779-2018
• Recall Event ID: 79950
• 510(K)Number: K112789
• Product Classification: Needle, hypodermic, single lumen - Product Code FMI
• Product: EasyTouch (ET) Insulin Syringe 29G 1ml " (Item 829155) Product Usage: INTENDED FOR INJECTION OF U100 INSULIN ONLY
• Code Information: Lot 45014
• Recalling Firm/ Manufacturer: MHC Medical Products LLC; 11930 Kemper Springs Dr; Cincinnati OH 45240-1642
• For Additional Information Contact: Jennifer S. Seiple; 877-358-4342
• Manufacturer Reason for Recall: The retail shelf cartons may be labeled with an incorrect lot number.
• FDA Determined Cause: Labeling mix-ups
• Action: Notification letters distributed on 4/6/18 and 4/11/18 included the following instructions: Please identify your total inventory for this device. The lot number for this device is a five-character, numeric representation (45014). This number can be located on the reverse side of the poly bag (immediate package) near the UDI /QR code. On the retail shelf carton, the lot number (45014) can be located on the rear panel near the UDI/QR code. Finally, the lot number (45014) can be located on the side panels of the case carton near the Item# and expiration date. Please take the following actions immediately: " Cease distribution of this lot number of devices; " Segregate the above described devices; " Complete the attached Consignee Reply Form and return it, even if you have no inventory on hand, to us using the enclosed self-addressed, stamped envelope, and " Return all unused devices from this lot in your inventory, if any, using via UPS Ground, UPS #A68W74 to the following address: MHC Medical Products, LLC c/o RXTPL 4200 Binion Way, Suite 200 Mason OH 45036 If you are a wholesaler (distributor), MHC is requesting that you notify any accounts or additional locations that may have received these recalled devices in lot 45014. If you prefer that MHC notify your customers, please provide MHC with a list of your companys customers that received or have been shipped the recalled lot 45014, including the customers name, shipping address, and contact phone number and/or e-mail address that you have on record. If you are a retail pharmacy, MHC is requesting you to notify your customers that received these recalled devices in lot 45014. Please instruct all customers to return the devices either to your pharmacy or instruct them to call the MHC customer service line (877-358-4342) and MHC will provide additional recall instructions directly to the customer. If you are a customer for whom MHC drop-ships devices to your end customer, please be aware that w
• Quantity in Commerce: 3137 retail units (313700 syringes)
• Distribution: US Nationwide Distribution in the states of: AR, AZ, CA, FL, GA, IL, IN, LA, MA, MI, MO, MS, NC, ND, NH, NJ, NV, NY, OH, PA, SC, TN, TX, VA, WA, WI, WV, and Puerto Rico.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = FMI